The role of prostate-specific antigen in light of new scientific evidence: An update in 2020 | Actas Urológicas Españolas (English Edition)

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Cózar, C. Hernández, B. Miñana, J. Morote, M.J. Alvarez-Cubero" "autores" => array:5 [ 0 => array:4 [ "nombre" => "J.M." "apellidos" => "Cózar" "email" => array:2 [ 0 => "cozarjm@yahoo.es" 1 => "aeu@aeu.com" ] "referencia" => array:3 [ 0 => array:2 [ "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "C." "apellidos" => "Hernández" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "b" "identificador" => "aff0010" ] ] ] 2 => array:3 [ "nombre" => "B." "apellidos" => "Miñana" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "c" "identificador" => "aff0015" ] ] ] 3 => array:3 [ "nombre" => "J." "apellidos" => "Morote" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "d" "identificador" => "aff0020" ] ] ] 4 => array:3 [ "nombre" => "M.J." "apellidos" => "Alvarez-Cubero" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "e" "identificador" => "aff0025" ] ] ] ] "afiliaciones" => array:5 [ 0 => array:3 [ "entidad" => "Servicio de Urología, Hospital Universitario Virgen de la Nieves, Granada, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Servicio de Urología, Hospital General Universitario Gregorio Marañón, Madrid, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Servicio de Urología, Hospital CUN de Madrid, Madrid, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Servicio de Urología, Hospital Universitario Vall de Hebron, Barcelona, Spain" "etiqueta" => "d" "identificador" => "aff0020" ] 4 => array:3 [ "entidad" => "Departamento de Bioquímica y Biología Molecular e Inmunología, Facultad de Medicina, Universidad de Granada, Granada, Spain" "etiqueta" => "e" "identificador" => "aff0025" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Papel del antígeno prostático específico ante las nuevas evidencias científicas, una nueva actualización en 2020" ] ] "textoCompleto" => "IntroductionIt is well known that the discovery of the prostate-specific antigen (PSA) revolutionized the specialty of urology in terms of more prostate cancer diagnosis, particularly at earlier stages. However, greater knowledge of the antigen enables us to improve the diagnosis of benign prostatic hypertrophy (BPH), to better predict its future behavior and stratify these patients in order to give them the most effective treatment. Seven years have passed since an in-depth review of the role of PSA was carried out in 2013,<a class="elsevierStyleCrossRef" href="#bib0005">1</a> and the new, relevant evidence has made us consider writing this new article to update the role of PSA in the male population.Likewise, the latest scientific evidence has allowed us to discriminate those patients who are at higher risk of developing prostate cancer when undergoing treatment with 5-alpha-reductase inhibitors. The new evidence has also defined the use of PSA in screening or early diagnosis of prostate cancer, as well as in its follow-up after using several treatments with curative intent. Similarly, the value of PSA as an efficient screening marker has increased in the past few years. In fact, recent publications have emphasized that the level of PSA in screening decreases overdiagnosis, indicating that stratification based on PSA could lead to a more efficient use of the PSA test in the early detection of prostate cancer.<a class="elsevierStyleCrossRef" href="#bib0010">2</a> It should be noted that the European Association of Urology has highlighted the role of PSA as an effective marker in reducing mortality from this tumor, which will lead to its clinical reassessment and incorporation across the European continent.Therefore, the role of PSA cannot only be considered relevant as an antigen for the evaluation of the risk of developing prostate cancer, or when assessing its evolution after curative or palliative treatment, but also when dealing with benign prostatic enlargement and as a significant screening molecule.Prostate-specific antigen as progression criterion of benign prostatic hypertrophyFor over a decade, there have been data in the literature which show the direct relationship between PSA levels and the risk of prostate enlargement and acute urinary retention (AUR). We are referring to the PLESS and PROSCAR studies.<a class="elsevierStyleCrossRefs" href="#bib0015">3,4</a> These same studies also reported the relationship between PSA levels and prostate volume.<a class="elsevierStyleCrossRef" href="#bib0025">5</a>The Olmsted County study,<a class="elsevierStyleCrossRef" href="#bib0030">6</a> carried out 2 years earlier, showed that the severity of lower urinary tract symptoms, urine flow, prostate volume, and the age of patients were the most important factors influencing the evolution of this disease. This same study also evaluated the expected annual PSA rise according to its baseline level and analyzed per tertiles: 0.2–1.3 ng/ml; 1.4–3.2 ng/ml and 3.3–9.9 ng/ml, with an increase of 0.7 ng/ml, 2.1 ng/ml and 3.3 ng/ml per year, respectively, which also helps the urologist when assessing the risk of tumor formation and, consequently, whether further evaluation is needed or not.A systematic review of these studies set a PSA threshold of 1.5 ng/ml/year<a class="elsevierStyleCrossRef" href="#bib0035">7</a> for predicting disease progression, although we do have to bear in mind that the PSA parameter should not be considered in isolation, but as stated above, age, urine flow, and the intensity of symptoms also have a significant impact.<a class="elsevierStyleCrossRef" href="#bib0040">8</a>Recent studies have determined that PSA and prostatic acid phosphatase (PSP) screening markers allow the detection and treatment of conditions such as prostatitis, BPH and prostate cancer. In the same way, a significantly higher increase in PSA has been found in prostatitis and prostate cancer compared to BPH.<a class="elsevierStyleCrossRef" href="#bib0045">9</a>Prostate-specific antigen and therapeutic management of benign prostatic hypertrophyThe 2 studies that provide more information about stratifying patients and, consequently, that more accurately indicate the most effective therapy are the MTOPS and the CombAT studies.<a class="elsevierStyleCrossRefs" href="#bib0050">10,11</a>The first study concluded that combination therapy, as well as treatment with finasteride, reduced the risk of BPH progression. However, this study was limited by the fact that the mean prostate volume of the men enrolled was about 30 cc.The risk of progression of BPH is very variable. The MTOPS data suggest that the benefits of medical therapy for BPH are unevenly distributed with men who were stratified at higher risk stages, accounting for the greatest clinical benefit. It must be highlighted that the application of the usually available baseline risk factors allows the estimation of patient-specific risk for clinical progression and, thus the potential for benefit. This study shows that the use of clinically available factors such as age, serum PSA and maximum flow rate, among others, may allow clinicians to better select those most likely to benefit from medical therapy for BPH and potentially inform future guidelines. Potential treatment effect can then be weighed against possible risks of adverse effects for a given patient.<a class="elsevierStyleCrossRef" href="#bib0060">12</a>The CombAT study, and above all the 4-year results<a class="elsevierStyleCrossRef" href="#bib0055">11</a> when analyzing 4.844 men with prostate volume greater than 30cm3, showed that using combination therapy or dutasteride in men with PSA levels >1.5 ng/ml and prostate volume >40cm3 reduces the risk of surgical treatment when compared to patients who only took tamsulosin, between 43 and 77%. Nevertheless, this improvement is not achieved when it comes to patients with a lower prostate volume.That is why we have data with scientific evidence levels 1b to discriminate between the various drugs (alpha blockers, 5-alpha-reductase inhibitors, and combination therapy) depending on prostate volume, symptom severity and PSA levels, knowing beforehand which treatment could be more effective in each case. The clinical guidelines and a large number of scientific associations, including the Spanish Association of Urology, have already added these criteria,<a class="elsevierStyleCrossRefs" href="#bib0065">13,14</a> and have even been subject to a Delphi method that tries to reach a consensus on scientific evidence and routine practice in the management of BPH by Spanish urologists.<a class="elsevierStyleCrossRef" href="#bib0075">15</a>Prostate-specific antigen in patients treated with 5-alpha-reductase inhibitorsLessons learned from the REDUCE study<a class="elsevierStyleCrossRef" href="#bib0080">16</a> show that the kinetics of PSA change when the patient is treated with dutasteride and, in this regard, a new basal PSA level should be established 6 months after therapy. This figure may decrease after this time period (until nadir PSA) if we are clearly faced with a patient with BPH. On the contrary, when we detect a confirmed increase above 0.3 ng/ml from the nadir achieved, even if we find PSA ranges within the normal parameters, the suspicion of either prostate cancer or non-compliance with treatment should be considered, and we should act accordingly based on the patient's life expectancy.There are currently new and different 5-alpha reductase inhibitors (5-ARI) formularies, so there is controversy about what to do in the face of PSA rise in situations other than treatment with dutasteride, for which the limits of PSA were already established.While all formularies decrease prostate volume, and thus PSA, these and their molecular affinities may not accomplish this decline to the same degree. The problem arises when an inadequate interpretation of PSA in patients with 5-ARI may lead to a delayed diagnosis of prostate cancer<a class="elsevierStyleCrossRef" href="#bib0090">18</a>; and switching 5-ARI drugs can be associated with a clinically significant change in PSA velocity, placing patients at risk for unnecessary biopsies.<a class="elsevierStyleCrossRef" href="#bib0085">17</a> In fact, recent studies conducted in a 3-month follow-up in patients with finasteride indicated that they did not increase the accuracy in predicting the outcome of the prostate biopsy within the 3-month period, but they had a significant effect on the values as PSA biomarkers. A proposal and need for adjustments in biopsy thresholds for men with finasteride was finally concluded.<a class="elsevierStyleCrossRef" href="#bib0095">19</a>In essence, the inferential analysis of all the published evidence on PSA in men with prostate disease allows us to affirm that:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005">1PSA has a direct relationship with prostate volume and with the risk of progression.</li><li class="elsevierStyleListItem" id="lsti0010">2PSA helps urologists stratify patients with BPH and decide upon the most appropriate treatment in each situation. In the case of a patient treated with dutasteride, a PSA  > 0,3 ng/ml rise from the nadir must raise suspicion on possible coexistence with prostatic adenocarcinoma.</li><li class="elsevierStyleListItem" id="lsti0015">3Currently there is controversy regarding treatment with 5-alpha reductase inhibitor derivatives (5-ARIs), with heterogenous opinions regarding the management of face of a PSA rise in situations other than treatment with dutasteride, for which the limits of PSA were already clear.</li><li class="elsevierStyleListItem" id="lsti0020">4The indication for prostate biopsy should be based on risk stratification of prostate cancer and insignificant cancer detection. This new clinical situation with 5 ARI formularies can lead to complex interpretations and to the indication of unnecessary prostate biopsies.</li></ul>Prostate-specific antigen in significant prostate cancer screeningPSA testing was approved by the Food and Drug Administration in 1994 for prostate cancer screening after the study carried out by Catalona et al., in which more than 6.000 men, with prior serum PSA measurement and digital rectal examination, were submitted to prostate biopsy. This study evidenced the complementarity of PSA and digital rectal examination as elements of suspicion of PCa, and it was estimated that the probability of detecting PCa in men with PSA < 4 ng/ml and a suspicious digital rectal examination was 20%, when PSA was between 4 and 10 ng/ml and digital rectal examination was normal, the probability was 30% and that it exceeded 50% with PSA figures above 10 ng/ml.<a class="elsevierStyleCrossRef" href="#bib0100">20</a>Widespread use of PSA testing led in the short term to a higher PCa incidence and also to earlier diagnoses. The diagnosis of patients with disseminated disease was drastically reduced and the proportion of patients diagnosed in clinically localized stages, when treatments with curative intent could be performed, was significantly increased. As a consequence, PCa mortality began to decrease. The effects of prostate cancer screening with PSA also spread soon to our field. Only 3% of cancers are currently diagnosed with disseminated disease, whereas this rate reached 40% in the 80 s. We have also gone from 20% in the 80 s to a current 70%.<a class="elsevierStyleCrossRef" href="#bib0105">21</a>In the first decade of the twenty-first century, the effectiveness of PSA as an element of suspicion of PCa was questioned, especially after the contribution of Stamey et al., in which the limited correlation between serum PSA levels and tumor volume and the relevant contribution of BPH to serum PSA concentration was revealed.<a class="elsevierStyleCrossRef" href="#bib0110">22</a> Thompson et al. analyzed the behavior of PSA in the control arm of the Prostate Cancer Prevention Trial and observed a progressive incidence of PCa in men with PSA < 4 ng/ml. PCa rates ranged from 6% in men with PSA < 1 ng/ml to about 25% when PSA was between 3-4 ng/ml.<a class="elsevierStyleCrossRef" href="#bib0115">23</a> These studies highlighted the lack of PSA specificity for detecting PCa, and thus the need for new markers or strategies was reported. However, since PSA was purified in 1979, it is known that it is a kallikrein specific to prostatic tissue, synthesized in the acinar and ductal epithelium of the gland, and it is exocrine-secreted to seminal fluid, where its physiological function is to liquefy semen. Elevation of serum PSA is caused by abnormal discharge into the bloodstream, as a consequence of inflammatory and neoplastic neovascularization processes, ruptured basement membrane and neoplastic stromal invasion, benign growth, prostate manipulation, etc.<a class="elsevierStyleCrossRef" href="#bib0120">24</a>In 1992, Benson et al. described PSA density to increase PSA specificity,<a class="elsevierStyleCrossRef" href="#bib0125">25</a> and in 1993, Oesterling et al. described age-specific PSA ranges.<a class="elsevierStyleCrossRef" href="#bib0130">26</a> Shortly after, the percentage of free PSA was also shown to be useful in increasing PSA specificity.<a class="elsevierStyleCrossRef" href="#bib0135">27</a> More recent advances aiming to increase the specificity of PSA, have focused on the discovery of new markers detected in urine after prostate massage, such as PCA3 or the combination of several genes.<a class="elsevierStyleCrossRef" href="#bib0140">28</a> The Prostate Health Index, which is a combination of all PSA isoforms determined in serum and integrated into a mathematical formula,<a class="elsevierStyleCrossRef" href="#bib0145">29</a> the 4 K test,<a class="elsevierStyleCrossRef" href="#bib0150">30</a> or even the very recent combination of cathepsin and thrombospondin.<a class="elsevierStyleCrossRef" href="#bib0155">31</a> However, multiparametric magnetic resonance imaging (mpMRI) has been the technique that has contributed most to improving the efficacy of PSA in the early diagnosis of PCa, since in addition to allowing the visualization of suspicious lesions, classified according to the risk of significant PCa, it has facilitated the introduction of targeted prostate biopsy. Thus, the early diagnosis of PCa is now specifically aimed at the detection of significant PCa, avoiding overdiagnosis of insignificant tumors, and for this purpose the paradigm of prostate biopsy has also changed, in which targeted and systematic biopsies are complemented.<a class="elsevierStyleCrossRef" href="#bib0160">32</a>We must mention the crisis of PSA reliability initiated in 2011 when the US Preventive Services Task Force (USPSTF) positioned against PSA-based screening for PCa. They mainly highlighted the harms derived from the diagnostic procedure, the overtreatment caused by overdiagnosis of insignificant tumors and the absence of reduction in mortality observed in the PCLO study.<a class="elsevierStyleCrossRef" href="#bib0165">33</a> Arguments demonstrating the limitations of the PCLO, which was the basis of the USPSTF positioning, were of little use and highlighted the high rate of contamination in the control group.<a class="elsevierStyleCrossRef" href="#bib0170">34</a> This fact was probably the reason why the results observed in the European Randomized Study of Screening for Prostate Cancer (ERSPC) were contrary to those observed in the PCLO. The ERSPC demonstrated a significant reduction in mortality in the screening arm at 7 years of follow-up. In this study, 182,000 men between ages 50 and 74 were randomized to PSA determinations and prostate biopsies every 4 years in comparison with a control group; at 13 years of follow-up, PSA screening had reduced specific mortality by 21%, equivalent to avoiding one death from every 27 patients with PCa diagnosis.<a class="elsevierStyleCrossRef" href="#bib0175">35</a> The positioning of the USPSTF resulted in the practical disappearance of opportunistic PCa screening in several countries. Over these 9 years, several countries such as the United Kingdom, where opportunistic PSA screening was cut back, have observed that up to 40% of new PCa diagnoses are made in locally advanced or disseminated stages.<a class="elsevierStyleCrossRef" href="#bib0180">36</a> In 2019, the United States recorded the first increase in prostate cancer mortality since 1990.<a class="elsevierStyleCrossRef" href="#bib0185">37</a> Recently, the results of the PCLO and ERSPC studies have been reconciled and have become more homogeneous. This is interpreted as the evolution of the PCLO’s control arm contamination bias over time.<a class="elsevierStyleCrossRef" href="#bib0190">38</a>Today, we have learned to make better use of PSA, discriminating between the population at significant risk of PCa according to their concentration at age 40 and 60.<a class="elsevierStyleCrossRef" href="#bib0195">39</a> The introduction of mpMRI has also played a crucial role in the avoidance of unnecessary biopsies, overdetection of indolent tumors, and increasing diagnosis of significant PCa through targeted biopsies. Finally, the USPSTF has also modified its positioning and opportunistic diagnosis of PCa seems to have become stronger,<a class="elsevierStyleCrossRefs" href="#bib0200">40,41</a> for which the use of predictive nomograms to increase the efficacy of early diagnosis programs has been greatly useful.<a class="elsevierStyleCrossRef" href="#bib0210">42</a>Prostate-specific antigen after focal therapyFocal therapy for CP is a therapeutic approach that seeks to cure or sufficiently alter the natural history of the disease to avoid impacting on the patient's life expectancy and quality of life; it lies between radical treatment and active surveillance. It involves treating the area of the prostate affected by the tumor while respecting healthy tissue, with the aim of preserving the urinary and sexual functions that can be compromised after radical treatments.<a class="elsevierStyleCrossRefs" href="#bib0215">43,44</a>The most commonly used therapeutic protocols are hemiablation or the treatment of unilateral or bilateral index lesions, with a safety margin. For this purpose, different techniques are used such as cryotherapy, HIFU, irreversible electroporation, photodynamic therapy, laser ablation or low/high-dose-rate brachytherapy.<a class="elsevierStyleCrossRefs" href="#bib0225">45–49</a>Currently, the systematic use of multiparametric MRI combined with targeted biopsies and with transperineal template and image fusion systems provide the best possible pre-treatment characterization of the neoplastic area.<a class="elsevierStyleCrossRefs" href="#bib0250">50,51</a> However, much of the reported experience regarding results comes from patients diagnosed after transrectal or transperineal biopsies, with or without previous multiparametric MRI, without using image fusion systems and mostly performing hemiablation. Although short- and medium-term outcomes are encouraging in terms of disease control and morbidity, a long term follow-up is warranted.<a class="elsevierStyleCrossRefs" href="#bib0260">52,53</a>Recurrence after focal therapy can be developed in the treated area due to insufficient ablation, or in the untreated area, due to the presence of a previous unnoticed tumor or de novo developed tumor within the follow-up period. Therefore, the main current challenges are the early detection of recurrences and choosing the most appropriate treatment.Curative success is defined by a negative follow-up biopsy, recommended within the first 12-24 months (protocolized biopsies) or before, in case of PSA persistence or rising velocity > 0.75 ng/ml (case biopsies). Apart from these evident situations, the role of PSA is not defined due to the persistence of the PSA normally produced by untreated tissue. Usually, all series show a PSA decline in variable proportion after hemiablation or focal treatment of the index lesion. In our experience when treating the index lesion with irreversible electroporation, we have observed a mean decline of 52% after 3 months of treatment, with a mean treated prostate volume of 12% of the gland. Using the same technique, other authors have reported 78% PSA decline after treatment of anterior tumors, probably because these are farther away from the neurovascular bundles, allowing larger volumes of tissue to be treated.<a class="elsevierStyleCrossRef" href="#bib0270">54</a>The kinetics of PSA after treatment, of which there is not much information in the published series, should include the presence of situations that can cause a progressive increase in PSA such as BPH or other non-malignant conditions as confounding factors.The PSA criteria for assessing the efficacy of radiotherapy treatment that have demonstrated prognostic influence, such as nadir reached, time to nadir and rise after nadir, have been used for focal therapy, especially in series of hemiablation of patients treated with HIFU or cryotherapy. However, it does not seem appropriate because radiotherapy treatment refers to the treatment of the entire gland and, since long-term results are not yet available, it could lead to delayed diagnosis of recurrence. In any case, the post-treatment nadir achieved may be a predictor of treatment failure, although in some studies it has shown little correlation with the presence of residual tumor in the biopsy.<a class="elsevierStyleCrossRef" href="#bib0275">55</a>In our opinion, the use of PSA density (PSAD) as a criterion for biopsy during follow-up seems particularly relevant, since it is assumed that, after ablation of the tumor with a safety margin, the remaining tissue should produce a PSA similar to that of a benign condition. In this sense, it has been proposed that a PSAD ≥ 0,1 ng/ml2 may be a good measure to predict the development of a tumor in the untreated area. In fact, certain studies with patients treated with HIFU have shown a good correlation of PSAD as a predictive factor of pattern 4 in the biopsy.<a class="elsevierStyleCrossRef" href="#bib0065">13</a> In any case, volume determination should be based on follow-up multiparametric MRI, given the inter-observer variability of external or transrectal ultrasound.<a class="elsevierStyleCrossRef" href="#bib0280">56</a>In the end, although the role of PSA in the follow-up of patients treated with focal therapy is not clear, it is called to play, along with MRI, a decisive role in face of post-treatment recurrence suspicion. The nadir reached after treatment, its kinetics (velocity and doubling time), and above all, PSA density must be the determinants for performing monitoring biopsies.Prostate-specific antigen in biochemical recurrence after radical treatment for prostate cancerAfter treatment with curative intent in prostate cancer, such as radical prostatectomy, external radiotherapy or brachytherapy or the combination of both, a percentage of patients will experience an elevation of their PSA levels over time, exceeding 30% incidence at 5 years in many series.<a class="elsevierStyleCrossRef" href="#bib0285">57</a> Follow-up and salvage treatment options have been evolving in recent years.In our review of the clinical guidelines published in 2012, there was still no consensus on the definition of biochemical recurrence or on its possible treatment.<a class="elsevierStyleCrossRef" href="#bib0290">58</a>Staging was based on the performance of bone scan and CT or MRI. The latter were indicated in the European Association of Urology Guidelines only for patients with PSA > 20 ng/ml levels, when no suspected areas of metastasis were detected, PSA levels, time until the appearance of biochemical recurrence, PSA doubling time, Gleason score and clinical or pathological stage were taken into consideration to consider the presence of local or distant recurrence and for counseling in terms of follow-up and/or treatment to administer.Early biochemical recurrence (within the first 12-18 months) after radical prostatectomy, was more likely to translate into disseminated disease, while a PSA rise three years after surgery would more likely be an indicator of local recurrence.<a class="elsevierStyleCrossRef" href="#bib0295">59</a>The PSA doubling time was evaluated in a similar way; if it was greater than 12 months or if we started at Gleason < 7 score, local recurrence was assumed, while, if the PSA doubling time was short and/or Gleason > 7 score, a higher possibility of disseminated disease was considered.When radical treatment had been performed through radiotherapy, a PSA > 2 years late rise, together with a long doubling time, suggested local recurrence, whereas an earlier and faster PSA rise would increase the possibility of metastasis. However, we were not able identify them with the imaging tests available in those years.<a class="elsevierStyleCrossRef" href="#bib0300">60</a>Based on these data, urologists had to decide upon the management of the disease: expectantly, with local radiotherapy, with salvage surgery or with hormone blockade.<a class="elsevierStyleCrossRef" href="#bib0305">61</a>Works with the use of choline PET-CT have been gradually appearing in the literature. For the detection of metastasis, these have reached a sensitivity of less than 30% with levels of PSA < 1 ng/ml, sensitivity that increased up to 70% and PSA > 3 ng/ml figures.<a class="elsevierStyleCrossRef" href="#bib0310">62</a> However, a meta-analysis published in 2013 concludes that this test has a low sensitivity, < 50% and a very high heterogenicity in its results, ranging from 22.7% to 78.4% according to the different publications.<a class="elsevierStyleCrossRef" href="#bib0315">63</a>After all, the indication of salvage lymphadenectomies began with the incorporation of this test, although the control of the disease achieved did not exceed 35% after 5 years of follow-up.<a class="elsevierStyleCrossRef" href="#bib0320">64</a>The technological evolution from 2015 onwards places a much more exquisite imaging technique in our hands, the 68Ga-PSMA-ligand PET-CT.<a class="elsevierStyleCrossRef" href="#bib0325">65</a>With this new radiotracer, it is possible to detect metastatic lesions in 75% of patients with biochemical recurrence and PSA levels between 1-2 ng/ml, and the positivity rate reaches up to 95% with higher levels such as 2 ng/ml.<a class="elsevierStyleCrossRef" href="#bib0330">66</a>The significant improvement that this imaging test represented in the early diagnosis of metastasis in biochemical recurrence, has introduced urologists to a scenario already defined for other tumors, but completely new in prostate cancer, such as the "oligo-metastatic" tumor, and its subsequent management with metastasis-directed therapy, after prior compliance with 3 premises: 1) early and evident identification of the metastasis; 2) complete eradication of the same; and 3) acceptable toxicity of the treatment for clinical implementation.<a class="elsevierStyleCrossRef" href="#bib0335">67</a>Publications from a decade ago had already shown in other solid tumors (colorectal, lung cancer, etc.) that surgical removal or radiotherapy treatment of tumors with a reduced number of metastases, no more than 3, achieved clearly higher survival rates than those more which were more disseminated.<a class="elsevierStyleCrossRefs" href="#bib0340">68,69</a>Going back to biochemical recurrence in prostate cancer, and despite the low sensitivity of the urological tests available until the middle of this decade, Tilki<a class="elsevierStyleCrossRef" href="#bib0350">70</a> analyses PSA levels prior to rescue lymphadenectomies, publishing that, when this surgical treatment was carried out in patients with PSA < 4/ml, cancer-specific survival at 5 years was > 80%, while it only reached 52% when surgery was performed in patients with PSAs that exceeded this threshold.And not only these figures must be taken into consideration, but it must be borne in mind that the involvement, mainly nodal, of the metastases, is outside the anatomical area of the pelvis in 22% of cases, and it would not be sufficient to perform a standard lymphadenectomy to control the disease.<a class="elsevierStyleCrossRef" href="#bib0355">71</a>Current reviews confirm that the use of more sensitive imaging tests, which identify more accurately the location of the metastatic lesion, helps us choose the therapeutic approach, increase the cure rates of these patients and reach biochemical response levels of 44.3% (mean), and a cancer-specific survival at 5 years of 84%.<a class="elsevierStyleCrossRef" href="#bib0360">72</a>Given that the first steps of spread in prostate cancer take place in the lymph node chains, treatments go through salvage lymphadenectomy, salvage radiotherapy or sometimes a combination of both depending on the location of the lesions.<a class="elsevierStyleCrossRef" href="#bib0355">71</a>They are all very safe techniques with a very low rate of complications, specifically salvage lymphadenectomy, and more so with the development of pure or robot-assisted laparoscopic surgery has continued to improve quality standards with hospital stays of no more than 2 days, little blood loss and virtually no effect on the quality of life of these patients.<a class="elsevierStyleCrossRef" href="#bib0365">73</a>In short, technological development, and the simultaneous appearance of more sensitive and specific diagnostic techniques, is achieving, in patients with biochemical recurrence after radical treatment of their prostate cancer, and when PSA levels are still low, the detection of a higher percentage of cases with oligometastatic lesions, mainly to the lymph nodes. The chances of treating them with salvage surgery or radiation therapy has now become a reality. The effect this may have on cancer-specific survival, or on delaying the start of systemic treatment, is still under discussion, and we are waiting for the results of ongoing clinical trials to determine whether or not to modify the therapeutic action on these patients.FundingThe expert meeting to analyze the available evidence has been funded by GSK.Conflict of interestThe authors declare that they have no conflict of interest." "textoCompletoSecciones" => array:1 [ "secciones" => array:13 [ 0 => array:3 [ "identificador" => "xres1445107" "titulo" => "Abstract" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Objective" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Evidence acquisition" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Evidence synthesis" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1318528" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres1445108" "titulo" => "Resumen" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Objetivo" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Adquisición de evidencia" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Síntesis de evidencia" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec1318529" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:2 [ "identificador" => "sec0010" "titulo" => "Prostate-specific antigen as progression criterion of benign prostatic hypertrophy" ] 6 => array:2 [ "identificador" => "sec0015" "titulo" => "Prostate-specific antigen and therapeutic management of benign prostatic hypertrophy" ] 7 => array:2 [ "identificador" => "sec0020" "titulo" => "Prostate-specific antigen in significant prostate cancer screening" ] 8 => array:2 [ "identificador" => "sec0025" "titulo" => "Prostate-specific antigen after focal therapy" ] 9 => array:2 [ "identificador" => "sec0030" "titulo" => "Prostate-specific antigen in biochemical recurrence after radical treatment for prostate cancer" ] 10 => array:2 [ "identificador" => "sec0035" "titulo" => "Funding" ] 11 => array:2 [ "identificador" => "sec0040" "titulo" => "Conflict of interest" ] 12 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2020-09-22" "fechaAceptado" => "2020-09-23" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1318528" "palabras" => array:4 [ 0 => "Prostate-specific antigen" 1 => "Benign prostatic hypertrophy" 2 => "Prostate adenocarcinoma" 3 => "5-alpha-reductase inhibitors" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1318529" "palabras" => array:4 [ 0 => "Antígeno prostático específico" 1 => "Hipertrofia prostática benigna" 2 => "Adenocarcinoma prostático" 3 => "Inhibidores-5-alfa-reductasa" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "ObjectiveTo review and update the latest scientific evidence gathered in recent years regarding prostate-specific antigen (PSA) for better implementation into routine clinical practice. Evidence acquisitionAnalysis of the available evidence on the current role of PSA, based on the experience of an expert panel in the subject under analysis. Evidence synthesisCurrently, PSA cannot be considered only as a guide for the presence or absence of prostate cancer. This determination can also help the urologist to decide on the most convenient treatment for a patient with benign prostatic hypertrophy (BPH) as a criterion for disease progression, and it can also suggest the suspicious existence of a prostatic tumor when there is PSA rise of >0.3 ng/ml over the level reached 6 months after having initiated treatment with 5-alpha-reductase inhibitor. However, the limits of this PSA rise with derivatives of alternative 5-alpha-reductase (5-ARI) inhibitors to dutasteride are controversial. Moreover, PSA is a key factor for the follow-up of patients with prostate adenocarcinoma at any stage who have received treatment (surgery, radiotherapy or focal therapies, hormone therapy), it acts as a guide to identify biochemical recurrence, to suspect the existence of local or distant recurrence, as well as to propose or discard adjuvant treatments. Finally, the role of PSA as a screening tool has been recently reinforced, demonstrating increased mortality rates or the existence of more aggressive cases of prostate cancer in those countries where the use of this tool has declined. ConclusionsWe present new data about the current role of PSA in the management of patients treated for BPH and/or prostate cancer that should be implemented into routine clinical practice, with special emphasis on the relevant role of this biomarker in the screening and follow-up of prostate cancer, as well as in the progression of BPH in dutasteride treatment." "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Objective" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Evidence acquisition" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Evidence synthesis" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "ObjetivoRevisar y actualizar las últimas evidencias científicas que se han producido en los últimos años con respecto al antígeno prostático específico (PSA) para su mejor aplicación en la práctica clínica habitual. Adquisición de evidenciaAnálisis de la evidencia disponible acerca del papel actual del PSA, según la consideración de un panel de expertos que recoge su experiencia en el tema analizado. Síntesis de evidenciaActualmente no puede considerarse el PSA únicamente un elemento orientativo en cuanto a la presencia o no de cáncer de próstata, sino que esta determinación ayuda al urólogo a indicar cuál es el tratamiento más conveniente ante un paciente con hipertrofia prostática benigna (HPB) como criterio de progresión de la enfermedad, así como a sospechar la existencia de un tumor prostático cuando la cifra de PSA se eleva>0,3 ng/ml en pacientes bajo tratamiento con inhibidor de 5-alfa-reductasa sobre la cifra alcanzada a los 6 meses de haber iniciado dicho tratamiento. Sin embargo, los límites de este aumento del PSA con derivados de inhibidores de la 5-alfa-reductasa (5-ARI) alternativos a la dutasterida están en controversia. Por otro lado el PSA resulta clave para el seguimiento de pacientes tratados de un carcinoma prostático en cualquier estadío y con cualquier opción (cirugía, radioterapia o terapias focales, hormonoterapia), para definir recidiva bioquímica, sospechar la existencia de recidiva local o a distancia, así como plantear o descartar tratamientos adyuvantes. Por ultimo, recientemente, se ha reforzado el papel del PSA como herramienta de screening demostrando unas tasas de aumento de mortalidad o de existencia de casos más agresivos de cáncer de próstata en aquellos países donde se ha disminuido el uso de esta herramienta. ConclusionesOfrecemos nuevos datos acerca del papel actual del PSA en el manejo de pacientes tratados por HPB y/o cáncer de próstata que deben tenerse en cuenta en la práctica clínica habitual, haciendo especial hincapié en el papel relevante de este biomarcador en el screening y seguimiento del cáncer de próstata, así como en la progresión de la HPB en tratamiento con dutasterida." "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Objetivo" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Adquisición de evidencia" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Síntesis de evidencia" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] ] "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "Please cite this article as: Cózar JM, Hernández C, Miñana B, Morote J, Alvarez-Cubero MJ. Papel del antígeno prostático específico ante las nuevas evidencias científicas, una nueva actualización en 2020. Actas Urol Esp. 2021;45:21–29." ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:73 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Papel del antígeno prostático específico ante las nuevas evidencias científicas" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:4 [ 0 => "C. Hernández" 1 => "J. Morote" 2 => "B. Miñana" 3 => "J. 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The role of prostate-specific antigen in light of new scientific evidence: An update in 2020

Papel del antígeno prostático específico ante las nuevas evidencias científicas, una nueva actualización en 2020

J.M. Cózara,b,

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cozarjm@yahoo.es
aeu@aeu.com

Corresponding author.

, C. Hernándezb, B. Miñanac, J. Moroted, M.J. Alvarez-Cuberoe

a Servicio de Urología, Hospital Universitario Virgen de la Nieves, Granada, Spain

b Servicio de Urología, Hospital General Universitario Gregorio Marañón, Madrid, Spain

c Servicio de Urología, Hospital CUN de Madrid, Madrid, Spain

d Servicio de Urología, Hospital Universitario Vall de Hebron, Barcelona, Spain

e Departamento de Bioquímica y Biología Molecular e Inmunología, Facultad de Medicina, Universidad de Granada, Granada, Spain

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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">It is well known that the discovery of the prostate-specific antigen &#40;PSA&#41; revolutionized the specialty of urology in terms of more prostate cancer diagnosis&#44; particularly at earlier stages&#46; However&#44; greater knowledge of the antigen enables us to improve the diagnosis of benign prostatic hypertrophy &#40;BPH&#41;&#44; to better predict its future behavior and stratify these patients in order to give them the most effective treatment&#46; Seven years have passed since an in-depth review of the role of PSA was carried out in 2013&#44;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> and the new&#44; relevant evidence has made us consider writing this new article to update the role of PSA in the male population&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">Likewise&#44; the latest scientific evidence has allowed us to discriminate those patients who are at higher risk of developing prostate cancer when undergoing treatment with 5-alpha-reductase inhibitors&#46; The new evidence has also defined the use of PSA in screening or early diagnosis of prostate cancer&#44; as well as in its follow-up after using several treatments with curative intent&#46; Similarly&#44; the value of PSA as an efficient screening marker has increased in the past few years&#46; In fact&#44; recent publications have emphasized that the level of PSA in screening decreases overdiagnosis&#44; indicating that stratification based on PSA could lead to a more efficient use of the PSA test in the early detection of prostate cancer&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> It should be noted that the European Association of Urology has highlighted the role of PSA as an effective marker in reducing mortality from this tumor&#44; which will lead to its clinical reassessment and incorporation across the European continent&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">Therefore&#44; the role of PSA cannot only be considered relevant as an antigen for the evaluation of the risk of developing prostate cancer&#44; or when assessing its evolution after curative or palliative treatment&#44; but also when dealing with benign prostatic enlargement and as a significant screening molecule&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Prostate-specific antigen as progression criterion of benign prostatic hypertrophy</span><p id="par0020" class="elsevierStylePara elsevierViewall">For over a decade&#44; there have been data in the literature which show the direct relationship between PSA levels and the risk of prostate enlargement and acute urinary retention &#40;AUR&#41;&#46; We are referring to the PLESS and PROSCAR studies&#46;<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">3&#44;4</span></a> These same studies also reported the relationship between PSA levels and prostate volume&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">The Olmsted County study&#44;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> carried out 2 years earlier&#44; showed that the severity of lower urinary tract symptoms&#44; urine flow&#44; prostate volume&#44; and the age of patients were the most important factors influencing the evolution of this disease&#46; This same study also evaluated the expected annual PSA rise according to its baseline level and analyzed per tertiles&#58; 0&#46;2&#8211;1&#46;3&#8239;ng&#47;ml&#59; 1&#46;4&#8211;3&#46;2&#8239;ng&#47;ml and 3&#46;3&#8211;9&#46;9&#8239;ng&#47;ml&#44; with an increase of 0&#46;7&#8239;ng&#47;ml&#44; 2&#46;1&#8239;ng&#47;ml and 3&#46;3&#8239;ng&#47;ml per year&#44; respectively&#44; which also helps the urologist when assessing the risk of tumor formation and&#44; consequently&#44; whether further evaluation is needed or not&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">A systematic review of these studies set a PSA threshold of 1&#46;5&#8239;ng&#47;ml&#47;year<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> for predicting disease progression&#44; although we do have to bear in mind that the PSA parameter should not be considered in isolation&#44; but as stated above&#44; age&#44; urine flow&#44; and the intensity of symptoms also have a significant impact&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">Recent studies have determined that PSA and prostatic acid phosphatase &#40;PSP&#41; screening markers allow the detection and treatment of conditions such as prostatitis&#44; BPH and prostate cancer&#46; In the same way&#44; a significantly higher increase in PSA has been found in prostatitis and prostate cancer compared to BPH&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a></p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Prostate-specific antigen and therapeutic management of benign prostatic hypertrophy</span><p id="par0040" class="elsevierStylePara elsevierViewall">The 2 studies that provide more information about stratifying patients and&#44; consequently&#44; that more accurately indicate the most effective therapy are the MTOPS and the CombAT studies&#46;<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">10&#44;11</span></a></p><p id="par0045" class="elsevierStylePara elsevierViewall">The first study concluded that combination therapy&#44; as well as treatment with finasteride&#44; reduced the risk of BPH progression&#46; However&#44; this study was limited by the fact that the mean prostate volume of the men enrolled was about 30&#8239;cc&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">The risk of progression of BPH is very variable&#46; The MTOPS data suggest that the benefits of medical therapy for BPH are unevenly distributed with men who were stratified at higher risk stages&#44; accounting for the greatest clinical benefit&#46; It must be highlighted that the application of the usually available baseline risk factors allows the estimation of patient-specific risk for clinical progression and&#44; thus the potential for benefit&#46; This study shows that the use of clinically available factors such as age&#44; serum PSA and maximum flow rate&#44; among others&#44; may allow clinicians to better select those most likely to benefit from medical therapy for BPH and potentially inform future guidelines&#46; Potential treatment effect can then be weighed against possible risks of adverse effects for a given patient&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">The CombAT study&#44; and above all the 4-year results<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> when analyzing 4&#46;844 men with prostate volume greater than 30cm<span class="elsevierStyleSup">3</span>&#44; showed that using combination therapy or dutasteride in men with PSA levels &#62;1&#46;5&#8239;ng&#47;ml and prostate volume &#62;40cm<span class="elsevierStyleSup">3</span> reduces the risk of surgical treatment when compared to patients who only took tamsulosin&#44; between 43 and 77&#37;&#46; Nevertheless&#44; this improvement is not achieved when it comes to patients with a lower prostate volume&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">That is why we have data with scientific evidence levels 1b to discriminate between the various drugs &#40;alpha blockers&#44; 5-alpha-reductase inhibitors&#44; and combination therapy&#41; depending on prostate volume&#44; symptom severity and PSA levels&#44; knowing beforehand which treatment could be more effective in each case&#46; The clinical guidelines and a large number of scientific associations&#44; including the Spanish Association of Urology&#44; have already added these criteria&#44;<a class="elsevierStyleCrossRefs" href="#bib0065"><span class="elsevierStyleSup">13&#44;14</span></a> and have even been subject to a Delphi method that tries to reach a consensus on scientific evidence and routine practice in the management of BPH by Spanish urologists&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a></p><p id="par0065" class="elsevierStylePara elsevierViewall">Prostate-specific antigen in patients treated with 5-alpha-reductase inhibitors</p><p id="par0070" class="elsevierStylePara elsevierViewall">Lessons learned from the REDUCE study<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> show that the kinetics of PSA change when the patient is treated with dutasteride and&#44; in this regard&#44; a new basal PSA level should be established 6 months after therapy&#46; This figure may decrease after this time period &#40;until nadir PSA&#41; if we are clearly faced with a patient with BPH&#46; On the contrary&#44; when we detect a confirmed increase above 0&#46;3&#8239;ng&#47;ml from the nadir achieved&#44; even if we find PSA ranges within the normal parameters&#44; the suspicion of either prostate cancer or non-compliance with treatment should be considered&#44; and we should act accordingly based on the patient&#39;s life expectancy&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">There are currently new and different 5-alpha reductase inhibitors &#40;5-ARI&#41; formularies&#44; so there is controversy about what to do in the face of PSA rise in situations other than treatment with dutasteride&#44; for which the limits of PSA were already established&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">While all formularies decrease prostate volume&#44; and thus PSA&#44; these and their molecular affinities may not accomplish this decline to the same degree&#46; The problem arises when an inadequate interpretation of PSA in patients with 5-ARI may lead to a delayed diagnosis of prostate cancer<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">18</span></a>&#59; and switching 5-ARI drugs can be associated with a clinically significant change in PSA velocity&#44; placing patients at risk for unnecessary biopsies&#46;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a> In fact&#44; recent studies conducted in a 3-month follow-up in patients with finasteride indicated that they did not increase the accuracy in predicting the outcome of the prostate biopsy within the 3-month period&#44; but they had a significant effect on the values as PSA biomarkers&#46; A proposal and need for adjustments in biopsy thresholds for men with finasteride was finally concluded&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">19</span></a></p><p id="par0085" class="elsevierStylePara elsevierViewall">In essence&#44; the inferential analysis of all the published evidence on PSA in men with prostate disease allows us to affirm that&#58;<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">1</span><p id="par0090" class="elsevierStylePara elsevierViewall">PSA has a direct relationship with prostate volume and with the risk of progression&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">2</span><p id="par0095" class="elsevierStylePara elsevierViewall">PSA helps urologists stratify patients with BPH and decide upon the most appropriate treatment in each situation&#46; In the case of a patient treated with dutasteride&#44; a PSA &#8239;&#62;&#8239;0&#44;3&#8239;ng&#47;ml rise from the nadir must raise suspicion on possible coexistence with prostatic adenocarcinoma&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">3</span><p id="par0100" class="elsevierStylePara elsevierViewall">Currently there is controversy regarding treatment with 5-alpha reductase inhibitor derivatives &#40;5-ARIs&#41;&#44; with heterogenous opinions regarding the management of face of a PSA rise in situations other than treatment with dutasteride&#44; for which the limits of PSA were already clear&#46;</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">4</span><p id="par0105" class="elsevierStylePara elsevierViewall">The indication for prostate biopsy should be based on risk stratification of prostate cancer and insignificant cancer detection&#46; This new clinical situation with 5&#8239;ARI formularies can lead to complex interpretations and to the indication of unnecessary prostate biopsies&#46;</p></li></ul></p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Prostate-specific antigen in significant prostate cancer screening</span><p id="par0110" class="elsevierStylePara elsevierViewall">PSA testing was approved by the Food and Drug Administration in 1994 for prostate cancer screening after the study carried out by Catalona et al&#46;&#44; in which more than 6&#46;000 men&#44; with prior serum PSA measurement and digital rectal examination&#44; were submitted to prostate biopsy&#46; This study evidenced the complementarity of PSA and digital rectal examination as elements of suspicion of PCa&#44; and it was estimated that the probability of detecting PCa in men with PSA&#8239;&#60;&#8239;4&#8239;ng&#47;ml and a suspicious digital rectal examination was 20&#37;&#44; when PSA was between 4 and 10&#8239;ng&#47;ml and digital rectal examination was normal&#44; the probability was 30&#37; and that it exceeded 50&#37; with PSA figures above 10&#8239;ng&#47;ml&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">20</span></a></p><p id="par0115" class="elsevierStylePara elsevierViewall">Widespread use of PSA testing led in the short term to a higher PCa incidence and also to earlier diagnoses&#46; The diagnosis of patients with disseminated disease was drastically reduced and the proportion of patients diagnosed in clinically localized stages&#44; when treatments with curative intent could be performed&#44; was significantly increased&#46; As a consequence&#44; PCa mortality began to decrease&#46; The effects of prostate cancer screening with PSA also spread soon to our field&#46; Only 3&#37; of cancers are currently diagnosed with disseminated disease&#44; whereas this rate reached 40&#37; in the 80&#8239;s&#46; We have also gone from 20&#37; in the 80&#8239;s to a current 70&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a></p><p id="par0120" class="elsevierStylePara elsevierViewall">In the first decade of the twenty-first century&#44; the effectiveness of PSA as an element of suspicion of PCa was questioned&#44; especially after the contribution of Stamey et al&#46;&#44; in which the limited correlation between serum PSA levels and tumor volume and the relevant contribution of BPH to serum PSA concentration was revealed&#46;<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">22</span></a> Thompson et al&#46; analyzed the behavior of PSA in the control arm of the Prostate Cancer Prevention Trial and observed a progressive incidence of PCa in men with PSA&#8239;&#60;&#8239;4&#8239;ng&#47;ml&#46; PCa rates ranged from 6&#37; in men with PSA&#8239;&#60;&#8239;1&#8239;ng&#47;ml to about 25&#37; when PSA was between 3-4&#8239;ng&#47;ml&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">23</span></a> These studies highlighted the lack of PSA specificity for detecting PCa&#44; and thus the need for new markers or strategies was reported&#46; However&#44; since PSA was purified in 1979&#44; it is known that it is a kallikrein specific to prostatic tissue&#44; synthesized in the acinar and ductal epithelium of the gland&#44; and it is exocrine-secreted to seminal fluid&#44; where its physiological function is to liquefy semen&#46; Elevation of serum PSA is caused by abnormal discharge into the bloodstream&#44; as a consequence of inflammatory and neoplastic neovascularization processes&#44; ruptured basement membrane and neoplastic stromal invasion&#44; benign growth&#44; prostate manipulation&#44; etc&#46;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">24</span></a></p><p id="par0125" class="elsevierStylePara elsevierViewall">In 1992&#44; Benson et al&#46; described PSA density to increase PSA specificity&#44;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">25</span></a> and in 1993&#44; Oesterling et al&#46; described age-specific PSA ranges&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">26</span></a> Shortly after&#44; the percentage of free PSA was also shown to be useful in increasing PSA specificity&#46;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">27</span></a> More recent advances aiming to increase the specificity of PSA&#44; have focused on the discovery of new markers detected in urine after prostate massage&#44; such as PCA3 or the combination of several genes&#46;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">28</span></a> The Prostate Health Index&#44; which is a combination of all PSA isoforms determined in serum and integrated into a mathematical formula&#44;<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">29</span></a> the 4&#8239;K test&#44;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">30</span></a> or even the very recent combination of cathepsin and thrombospondin&#46;<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">31</span></a> However&#44; multiparametric magnetic resonance imaging &#40;mpMRI&#41; has been the technique that has contributed most to improving the efficacy of PSA in the early diagnosis of PCa&#44; since in addition to allowing the visualization of suspicious lesions&#44; classified according to the risk of significant PCa&#44; it has facilitated the introduction of targeted prostate biopsy&#46; Thus&#44; the early diagnosis of PCa is now specifically aimed at the detection of significant PCa&#44; avoiding overdiagnosis of insignificant tumors&#44; and for this purpose the paradigm of prostate biopsy has also changed&#44; in which targeted and systematic biopsies are complemented&#46;<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">32</span></a></p><p id="par0130" class="elsevierStylePara elsevierViewall">We must mention the crisis of PSA reliability initiated in 2011 when the US Preventive Services Task Force &#40;USPSTF&#41; positioned against PSA-based screening for PCa&#46; They mainly highlighted the harms derived from the diagnostic procedure&#44; the overtreatment caused by overdiagnosis of insignificant tumors and the absence of reduction in mortality observed in the PCLO study&#46;<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">33</span></a> Arguments demonstrating the limitations of the PCLO&#44; which was the basis of the USPSTF positioning&#44; were of little use and highlighted the high rate of contamination in the control group&#46;<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">34</span></a> This fact was probably the reason why the results observed in the European Randomized Study of Screening for Prostate Cancer &#40;ERSPC&#41; were contrary to those observed in the PCLO&#46; The ERSPC demonstrated a significant reduction in mortality in the screening arm at 7 years of follow-up&#46; In this study&#44; 182&#44;000 men between ages 50 and 74 were randomized to PSA determinations and prostate biopsies every 4 years in comparison with a control group&#59; at 13 years of follow-up&#44; PSA screening had reduced specific mortality by 21&#37;&#44; equivalent to avoiding one death from every 27 patients with PCa diagnosis&#46;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">35</span></a> The positioning of the USPSTF resulted in the practical disappearance of opportunistic PCa screening in several countries&#46; Over these 9 years&#44; several countries such as the United Kingdom&#44; where opportunistic PSA screening was cut back&#44; have observed that up to 40&#37; of new PCa diagnoses are made in locally advanced or disseminated stages&#46;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">36</span></a> In 2019&#44; the United States recorded the first increase in prostate cancer mortality since 1990&#46;<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">37</span></a> Recently&#44; the results of the PCLO and ERSPC studies have been reconciled and have become more homogeneous&#46; This is interpreted as the evolution of the PCLO&#8217;s control arm contamination bias over time&#46;<a class="elsevierStyleCrossRef" href="#bib0190"><span class="elsevierStyleSup">38</span></a></p><p id="par0135" class="elsevierStylePara elsevierViewall">Today&#44; we have learned to make better use of PSA&#44; discriminating between the population at significant risk of PCa according to their concentration at age 40 and 60&#46;<a class="elsevierStyleCrossRef" href="#bib0195"><span class="elsevierStyleSup">39</span></a> The introduction of mpMRI has also played a crucial role in the avoidance of unnecessary biopsies&#44; overdetection of indolent tumors&#44; and increasing diagnosis of significant PCa through targeted biopsies&#46; Finally&#44; the USPSTF has also modified its positioning and opportunistic diagnosis of PCa seems to have become stronger&#44;<a class="elsevierStyleCrossRefs" href="#bib0200"><span class="elsevierStyleSup">40&#44;41</span></a> for which the use of predictive nomograms to increase the efficacy of early diagnosis programs has been greatly useful&#46;<a class="elsevierStyleCrossRef" href="#bib0210"><span class="elsevierStyleSup">42</span></a></p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Prostate-specific antigen after focal therapy</span><p id="par0140" class="elsevierStylePara elsevierViewall">Focal therapy for CP is a therapeutic approach that seeks to cure or sufficiently alter the natural history of the disease to avoid impacting on the patient&#39;s life expectancy and quality of life&#59; it lies between radical treatment and active surveillance&#46; It involves treating the area of the prostate affected by the tumor while respecting healthy tissue&#44; with the aim of preserving the urinary and sexual functions that can be compromised after radical treatments&#46;<a class="elsevierStyleCrossRefs" href="#bib0215"><span class="elsevierStyleSup">43&#44;44</span></a></p><p id="par0145" class="elsevierStylePara elsevierViewall">The most commonly used therapeutic protocols are hemiablation or the treatment of unilateral or bilateral index lesions&#44; with a safety margin&#46; For this purpose&#44; different techniques are used such as cryotherapy&#44; HIFU&#44; irreversible electroporation&#44; photodynamic therapy&#44; laser ablation or low&#47;high-dose-rate brachytherapy&#46;<a class="elsevierStyleCrossRefs" href="#bib0225"><span class="elsevierStyleSup">45&#8211;49</span></a></p><p id="par0150" class="elsevierStylePara elsevierViewall">Currently&#44; the systematic use of multiparametric MRI combined with targeted biopsies and with transperineal template and image fusion systems provide the best possible pre-treatment characterization of the neoplastic area&#46;<a class="elsevierStyleCrossRefs" href="#bib0250"><span class="elsevierStyleSup">50&#44;51</span></a> However&#44; much of the reported experience regarding results comes from patients diagnosed after transrectal or transperineal biopsies&#44; with or without previous multiparametric MRI&#44; without using image fusion systems and mostly performing hemiablation&#46; Although short- and medium-term outcomes are encouraging in terms of disease control and morbidity&#44; a long term follow-up is warranted&#46;<a class="elsevierStyleCrossRefs" href="#bib0260"><span class="elsevierStyleSup">52&#44;53</span></a></p><p id="par0155" class="elsevierStylePara elsevierViewall">Recurrence after focal therapy can be developed in the treated area due to insufficient ablation&#44; or in the untreated area&#44; due to the presence of a previous unnoticed tumor or de novo developed tumor within the follow-up period&#46; Therefore&#44; the main current challenges are the early detection of recurrences and choosing the most appropriate treatment&#46;</p><p id="par0160" class="elsevierStylePara elsevierViewall">Curative success is defined by a negative follow-up biopsy&#44; recommended within the first 12-24 months &#40;protocolized biopsies&#41; or before&#44; in case of PSA persistence or rising velocity&#8239;&#62;&#8239;0&#46;75&#8239;ng&#47;ml &#40;case biopsies&#41;&#46; Apart from these evident situations&#44; the role of PSA is not defined due to the persistence of the PSA normally produced by untreated tissue&#46; Usually&#44; all series show a PSA decline in variable proportion after hemiablation or focal treatment of the index lesion&#46; In our experience when treating the index lesion with irreversible electroporation&#44; we have observed a mean decline of 52&#37; after 3 months of treatment&#44; with a mean treated prostate volume of 12&#37; of the gland&#46; Using the same technique&#44; other authors have reported 78&#37; PSA decline after treatment of anterior tumors&#44; probably because these are farther away from the neurovascular bundles&#44; allowing larger volumes of tissue to be treated&#46;<a class="elsevierStyleCrossRef" href="#bib0270"><span class="elsevierStyleSup">54</span></a></p><p id="par0165" class="elsevierStylePara elsevierViewall">The kinetics of PSA after treatment&#44; of which there is not much information in the published series&#44; should include the presence of situations that can cause a progressive increase in PSA such as BPH or other non-malignant conditions as confounding factors&#46;</p><p id="par0170" class="elsevierStylePara elsevierViewall">The PSA criteria for assessing the efficacy of radiotherapy treatment that have demonstrated prognostic influence&#44; such as nadir reached&#44; time to nadir and rise after nadir&#44; have been used for focal therapy&#44; especially in series of hemiablation of patients treated with HIFU or cryotherapy&#46; However&#44; it does not seem appropriate because radiotherapy treatment refers to the treatment of the entire gland and&#44; since long-term results are not yet available&#44; it could lead to delayed diagnosis of recurrence&#46; In any case&#44; the post-treatment nadir achieved may be a predictor of treatment failure&#44; although in some studies it has shown little correlation with the presence of residual tumor in the biopsy&#46;<a class="elsevierStyleCrossRef" href="#bib0275"><span class="elsevierStyleSup">55</span></a></p><p id="par0175" class="elsevierStylePara elsevierViewall">In our opinion&#44; the use of PSA density &#40;PSAD&#41; as a criterion for biopsy during follow-up seems particularly relevant&#44; since it is assumed that&#44; after ablation of the tumor with a safety margin&#44; the remaining tissue should produce a PSA similar to that of a benign condition&#46; In this sense&#44; it has been proposed that a PSAD&#8239;&#8805;&#8239;0&#44;1&#8239;ng&#47;ml<span class="elsevierStyleSup">2</span> may be a good measure to predict the development of a tumor in the untreated area&#46; In fact&#44; certain studies with patients treated with HIFU have shown a good correlation of PSAD as a predictive factor of pattern 4 in the biopsy&#46;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a> In any case&#44; volume determination should be based on follow-up multiparametric MRI&#44; given the inter-observer variability of external or transrectal ultrasound&#46;<a class="elsevierStyleCrossRef" href="#bib0280"><span class="elsevierStyleSup">56</span></a></p><p id="par0180" class="elsevierStylePara elsevierViewall">In the end&#44; although the role of PSA in the follow-up of patients treated with focal therapy is not clear&#44; it is called to play&#44; along with MRI&#44; a decisive role in face of post-treatment recurrence suspicion&#46; The nadir reached after treatment&#44; its kinetics &#40;velocity and doubling time&#41;&#44; and above all&#44; PSA density must be the determinants for performing monitoring biopsies&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Prostate-specific antigen in biochemical recurrence after radical treatment for prostate cancer</span><p id="par0185" class="elsevierStylePara elsevierViewall">After treatment with curative intent in prostate cancer&#44; such as radical prostatectomy&#44; external radiotherapy or brachytherapy or the combination of both&#44; a percentage of patients will experience an elevation of their PSA levels over time&#44; exceeding 30&#37; incidence at 5 years in many series&#46;<a class="elsevierStyleCrossRef" href="#bib0285"><span class="elsevierStyleSup">57</span></a> Follow-up and salvage treatment options have been evolving in recent years&#46;</p><p id="par0190" class="elsevierStylePara elsevierViewall">In our review of the clinical guidelines published in 2012&#44; there was still no consensus on the definition of biochemical recurrence or on its possible treatment&#46;<a class="elsevierStyleCrossRef" href="#bib0290"><span class="elsevierStyleSup">58</span></a></p><p id="par0195" class="elsevierStylePara elsevierViewall">Staging was based on the performance of bone scan and CT or MRI&#46; The latter were indicated in the European Association of Urology Guidelines only for patients with PSA&#8239;&#62;&#8239;20&#8239;ng&#47;ml levels&#44; when no suspected areas of metastasis were detected&#44; PSA levels&#44; time until the appearance of biochemical recurrence&#44; PSA doubling time&#44; Gleason score and clinical or pathological stage were taken into consideration to consider the presence of local or distant recurrence and for counseling in terms of follow-up and&#47;or treatment to administer&#46;</p><p id="par0200" class="elsevierStylePara elsevierViewall">Early biochemical recurrence &#40;within the first 12-18&#8239;months&#41; after radical prostatectomy&#44; was more likely to translate into disseminated disease&#44; while a PSA rise three years after surgery would more likely be an indicator of local recurrence&#46;<a class="elsevierStyleCrossRef" href="#bib0295"><span class="elsevierStyleSup">59</span></a></p><p id="par0205" class="elsevierStylePara elsevierViewall">The PSA doubling time was evaluated in a similar way&#59; if it was greater than 12 months or if we started at Gleason&#8239;&#60;&#8239;7 score&#44; local recurrence was assumed&#44; while&#44; if the PSA doubling time was short and&#47;or Gleason&#8239;&#62;&#8239;7 score&#44; a higher possibility of disseminated disease was considered&#46;</p><p id="par0210" class="elsevierStylePara elsevierViewall">When radical treatment had been performed through radiotherapy&#44; a PSA&#8239;&#62;&#8239;2 years late rise&#44; together with a long doubling time&#44; suggested local recurrence&#44; whereas an earlier and faster PSA rise would increase the possibility of metastasis&#46; However&#44; we were not able identify them with the imaging tests available in those years&#46;<a class="elsevierStyleCrossRef" href="#bib0300"><span class="elsevierStyleSup">60</span></a></p><p id="par0215" class="elsevierStylePara elsevierViewall">Based on these data&#44; urologists had to decide upon the management of the disease&#58; expectantly&#44; with local radiotherapy&#44; with salvage surgery or with hormone blockade&#46;<a class="elsevierStyleCrossRef" href="#bib0305"><span class="elsevierStyleSup">61</span></a></p><p id="par0220" class="elsevierStylePara elsevierViewall">Works with the use of choline PET-CT have been gradually appearing in the literature&#46; For the detection of metastasis&#44; these have reached a sensitivity of less than 30&#37; with levels of PSA&#8239;&#60;&#8239;1&#8239;ng&#47;ml&#44; sensitivity that increased up to 70&#37; and PSA&#8239;&#62;&#8239;3&#8239;ng&#47;ml figures&#46;<a class="elsevierStyleCrossRef" href="#bib0310"><span class="elsevierStyleSup">62</span></a> However&#44; a meta-analysis published in 2013 concludes that this test has a low sensitivity&#44;&#8239;&#60;&#8239;50&#37; and a very high heterogenicity in its results&#44; ranging from 22&#46;7&#37; to 78&#46;4&#37; according to the different publications&#46;<a class="elsevierStyleCrossRef" href="#bib0315"><span class="elsevierStyleSup">63</span></a></p><p id="par0225" class="elsevierStylePara elsevierViewall">After all&#44; the indication of salvage lymphadenectomies began with the incorporation of this test&#44; although the control of the disease achieved did not exceed 35&#37; after 5 years of follow-up&#46;<a class="elsevierStyleCrossRef" href="#bib0320"><span class="elsevierStyleSup">64</span></a></p><p id="par0230" class="elsevierStylePara elsevierViewall">The technological evolution from 2015 onwards places a much more exquisite imaging technique in our hands&#44; the <span class="elsevierStyleSup">68</span>Ga-PSMA-ligand PET-CT&#46;<a class="elsevierStyleCrossRef" href="#bib0325"><span class="elsevierStyleSup">65</span></a></p><p id="par0235" class="elsevierStylePara elsevierViewall">With this new radiotracer&#44; it is possible to detect metastatic lesions in 75&#37; of patients with biochemical recurrence and PSA levels between 1-2&#8239;ng&#47;ml&#44; and the positivity rate reaches up to 95&#37; with higher levels such as 2&#8239;ng&#47;ml&#46;<a class="elsevierStyleCrossRef" href="#bib0330"><span class="elsevierStyleSup">66</span></a></p><p id="par0240" class="elsevierStylePara elsevierViewall">The significant improvement that this imaging test represented in the early diagnosis of metastasis in biochemical recurrence&#44; has introduced urologists to a scenario already defined for other tumors&#44; but completely new in prostate cancer&#44; such as the &#34;oligo-metastatic&#34; tumor&#44; and its subsequent management with metastasis-directed therapy&#44; after prior compliance with 3 premises&#58; 1&#41; early and evident identification of the metastasis&#59; 2&#41; complete eradication of the same&#59; and 3&#41; acceptable toxicity of the treatment for clinical implementation&#46;<a class="elsevierStyleCrossRef" href="#bib0335"><span class="elsevierStyleSup">67</span></a></p><p id="par0245" class="elsevierStylePara elsevierViewall">Publications from a decade ago had already shown in other solid tumors &#40;colorectal&#44; lung cancer&#44; etc&#46;&#41; that surgical removal or radiotherapy treatment of tumors with a reduced number of metastases&#44; no more than 3&#44; achieved clearly higher survival rates than those more which were more disseminated&#46;<a class="elsevierStyleCrossRefs" href="#bib0340"><span class="elsevierStyleSup">68&#44;69</span></a></p><p id="par0250" class="elsevierStylePara elsevierViewall">Going back to biochemical recurrence in prostate cancer&#44; and despite the low sensitivity of the urological tests available until the middle of this decade&#44; Tilki<a class="elsevierStyleCrossRef" href="#bib0350"><span class="elsevierStyleSup">70</span></a> analyses PSA levels prior to rescue lymphadenectomies&#44; publishing that&#44; when this surgical treatment was carried out in patients with PSA&#8239;&#60;&#8239;4&#47;ml&#44; cancer-specific survival at 5 years was&#8239;&#62;&#8239;80&#37;&#44; while it only reached 52&#37; when surgery was performed in patients with PSAs that exceeded this threshold&#46;</p><p id="par0255" class="elsevierStylePara elsevierViewall">And not only these figures must be taken into consideration&#44; but it must be borne in mind that the involvement&#44; mainly nodal&#44; of the metastases&#44; is outside the anatomical area of the pelvis in 22&#37; of cases&#44; and it would not be sufficient to perform a standard lymphadenectomy to control the disease&#46;<a class="elsevierStyleCrossRef" href="#bib0355"><span class="elsevierStyleSup">71</span></a></p><p id="par0260" class="elsevierStylePara elsevierViewall">Current reviews confirm that the use of more sensitive imaging tests&#44; which identify more accurately the location of the metastatic lesion&#44; helps us choose the therapeutic approach&#44; increase the cure rates of these patients and reach biochemical response levels of 44&#46;3&#37; &#40;mean&#41;&#44; and a cancer-specific survival at 5 years of 84&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0360"><span class="elsevierStyleSup">72</span></a></p><p id="par0265" class="elsevierStylePara elsevierViewall">Given that the first steps of spread in prostate cancer take place in the lymph node chains&#44; treatments go through salvage lymphadenectomy&#44; salvage radiotherapy or sometimes a combination of both depending on the location of the lesions&#46;<a class="elsevierStyleCrossRef" href="#bib0355"><span class="elsevierStyleSup">71</span></a></p><p id="par0270" class="elsevierStylePara elsevierViewall">They are all very safe techniques with a very low rate of complications&#44; specifically salvage lymphadenectomy&#44; and more so with the development of pure or robot-assisted laparoscopic surgery has continued to improve quality standards with hospital stays of no more than 2 days&#44; little blood loss and virtually no effect on the quality of life of these patients&#46;<a class="elsevierStyleCrossRef" href="#bib0365"><span class="elsevierStyleSup">73</span></a></p><p id="par0275" class="elsevierStylePara elsevierViewall">In short&#44; technological development&#44; and the simultaneous appearance of more sensitive and specific diagnostic techniques&#44; is achieving&#44; in patients with biochemical recurrence after radical treatment of their prostate cancer&#44; and when PSA levels are still low&#44; the detection of a higher percentage of cases with oligometastatic lesions&#44; mainly to the lymph nodes&#46; The chances of treating them with salvage surgery or radiation therapy has now become a reality&#46; The effect this may have on cancer-specific survival&#44; or on delaying the start of systemic treatment&#44; is still under discussion&#44; and we are waiting for the results of ongoing clinical trials to determine whether or not to modify the therapeutic action on these patients&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Funding</span><p id="par0280" class="elsevierStylePara elsevierViewall">The expert meeting to analyze the available evidence has been funded by <span class="elsevierStyleGrantSponsor" id="gs0005">GSK</span>&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Conflict of interest</span><p id="par0285" class="elsevierStylePara elsevierViewall">The authors declare that they have no conflict of interest&#46;</p></span></span>"
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          "titulo" => "Prostate-specific antigen in significant prostate cancer screening"
        ]
        8 => array:2 [
          "identificador" => "sec0025"
          "titulo" => "Prostate-specific antigen after focal therapy"
        ]
        9 => array:2 [
          "identificador" => "sec0030"
          "titulo" => "Prostate-specific antigen in biochemical recurrence after radical treatment for prostate cancer"
        ]
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          "identificador" => "sec0035"
          "titulo" => "Funding"
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          "titulo" => "Conflict of interest"
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          "titulo" => "References"
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    ]
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    "tienePdf" => true
    "fechaRecibido" => "2020-09-22"
    "fechaAceptado" => "2020-09-23"
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        0 => array:4 [
          "clase" => "keyword"
          "titulo" => "Keywords"
          "identificador" => "xpalclavsec1318528"
          "palabras" => array:4 [
            0 => "Prostate-specific antigen"
            1 => "Benign prostatic hypertrophy"
            2 => "Prostate adenocarcinoma"
            3 => "5-alpha-reductase inhibitors"
          ]
        ]
      ]
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        0 => array:4 [
          "clase" => "keyword"
          "titulo" => "Palabras clave"
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          "palabras" => array:4 [
            0 => "Ant&#237;geno prost&#225;tico espec&#237;fico"
            1 => "Hipertrofia prost&#225;tica benigna"
            2 => "Adenocarcinoma prost&#225;tico"
            3 => "Inhibidores-5-alfa-reductasa"
          ]
        ]
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      "en" => array:3 [
        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Objective</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">To review and update the latest scientific evidence gathered in recent years regarding prostate-specific antigen &#40;PSA&#41; for better implementation into routine clinical practice&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Evidence acquisition</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Analysis of the available evidence on the current role of PSA&#44; based on the experience of an expert panel in the subject under analysis&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Evidence synthesis</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Currently&#44; PSA cannot be considered only as a guide for the presence or absence of prostate cancer&#46; This determination can also help the urologist to decide on the most convenient treatment for a patient with benign prostatic hypertrophy &#40;BPH&#41; as a criterion for disease progression&#44; and it can also suggest the suspicious existence of a prostatic tumor when there is PSA rise of &#62;0&#46;3&#8239;ng&#47;ml over the level reached 6 months after having initiated treatment with 5-alpha-reductase inhibitor&#46; However&#44; the limits of this PSA rise with derivatives of alternative 5-alpha-reductase &#40;5-ARI&#41; inhibitors to dutasteride are controversial&#46; Moreover&#44; PSA is a key factor for the follow-up of patients with prostate adenocarcinoma at any stage who have received treatment &#40;surgery&#44; radiotherapy or focal therapies&#44; hormone therapy&#41;&#44; it acts as a guide to identify biochemical recurrence&#44; to suspect the existence of local or distant recurrence&#44; as well as to propose or discard adjuvant treatments&#46; Finally&#44; the role of PSA as a screening tool has been recently reinforced&#44; demonstrating increased mortality rates or the existence of more aggressive cases of prostate cancer in those countries where the use of this tool has declined&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">We present new data about the current role of PSA in the management of patients treated for BPH and&#47;or prostate cancer that should be implemented into routine clinical practice&#44; with special emphasis on the relevant role of this biomarker in the screening and follow-up of prostate cancer&#44; as well as in the progression of BPH in dutasteride treatment&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abst0005"
            "titulo" => "Objective"
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          1 => array:2 [
            "identificador" => "abst0010"
            "titulo" => "Evidence acquisition"
          ]
          2 => array:2 [
            "identificador" => "abst0015"
            "titulo" => "Evidence synthesis"
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          3 => array:2 [
            "identificador" => "abst0020"
            "titulo" => "Conclusions"
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      "es" => array:3 [
        "titulo" => "Resumen"
        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Objetivo</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Revisar y actualizar las &#250;ltimas evidencias cient&#237;ficas que se han producido en los &#250;ltimos a&#241;os con respecto al ant&#237;geno prost&#225;tico espec&#237;fico &#40;PSA&#41; para su mejor aplicaci&#243;n en la pr&#225;ctica cl&#237;nica habitual&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Adquisici&#243;n de evidencia</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">An&#225;lisis de la evidencia disponible acerca del papel actual del PSA&#44; seg&#250;n la consideraci&#243;n de un panel de expertos que recoge su experiencia en el tema analizado&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">S&#237;ntesis de evidencia</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Actualmente no puede considerarse el PSA &#250;nicamente un elemento orientativo en cuanto a la presencia o no de c&#225;ncer de pr&#243;stata&#44; sino que esta determinaci&#243;n ayuda al ur&#243;logo a indicar cu&#225;l es el tratamiento m&#225;s conveniente ante un paciente con hipertrofia prost&#225;tica benigna &#40;HPB&#41; como criterio de progresi&#243;n de la enfermedad&#44; as&#237; como a sospechar la existencia de un tumor prost&#225;tico cuando la cifra de PSA se eleva&#62;0&#44;3&#8239;ng&#47;ml en pacientes bajo tratamiento con inhibidor de 5-alfa-reductasa sobre la cifra alcanzada a los 6 meses de haber iniciado dicho tratamiento&#46; Sin embargo&#44; los l&#237;mites de este aumento del PSA con derivados de inhibidores de la 5-alfa-reductasa &#40;5-ARI&#41; alternativos a la dutasterida est&#225;n en controversia&#46; Por otro lado el PSA resulta clave para el seguimiento de pacientes tratados de un carcinoma prost&#225;tico en cualquier estad&#237;o y con cualquier opci&#243;n &#40;cirug&#237;a&#44; radioterapia o terapias focales&#44; hormonoterapia&#41;&#44; para definir recidiva bioqu&#237;mica&#44; sospechar la existencia de recidiva local o a distancia&#44; as&#237; como plantear o descartar tratamientos adyuvantes&#46; Por ultimo&#44; recientemente&#44; se ha reforzado el papel del PSA como herramienta de screening demostrando unas tasas de aumento de mortalidad o de existencia de casos m&#225;s agresivos de c&#225;ncer de pr&#243;stata en aquellos pa&#237;ses donde se ha disminuido el uso de esta herramienta&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Ofrecemos nuevos datos acerca del papel actual del PSA en el manejo de pacientes tratados por HPB y&#47;o c&#225;ncer de pr&#243;stata que deben tenerse en cuenta en la pr&#225;ctica cl&#237;nica habitual&#44; haciendo especial hincapi&#233; en el papel relevante de este biomarcador en el screening y seguimiento del c&#225;ncer de pr&#243;stata&#44; as&#237; como en la progresi&#243;n de la HPB en tratamiento con dutasterida&#46;</p></span>"
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            "titulo" => "S&#237;ntesis de evidencia"
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            "titulo" => "Conclusiones"
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    "NotaPie" => array:1 [
      0 => array:2 [
        "etiqueta" => "&#9734;"
        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; C&#243;zar JM&#44; Hern&#225;ndez C&#44; Mi&#241;ana B&#44; Morote J&#44; Alvarez-Cubero MJ&#46; Papel del ant&#237;geno prost&#225;tico espec&#237;fico ante las nuevas evidencias cient&#237;ficas&#44; una nueva actualizaci&#243;n en 2020&#46; Actas Urol Esp&#46; 2021&#59;45&#58;21&#8211;29&#46;</p>"
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    ]
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                      "titulo" => "Biomarkers of prostatic cancer&#58; an attempt to categorize patients into prostatic carcinoma&#44; benign prostatic hyperplasia&#44; or prostatitis based on serum prostate specific antigen&#44; prostatic acid phosphatase&#44; calcium&#44; and phosphorus"
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